Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring

Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01362868

Enrollment

Registered

2011-05-30

Start date

2011-05-31

Completion date

2011-11-30

Last updated

2011-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Glaucoma, Triggerfish, Water drinking test

Brief summary

The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.

Detailed description

32 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 4-6-hour continuous IOP monitoring with SENSIMED Triggerfish® following water drinking test (WDT). SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Sensor fitting in the eye will then be evaluated every 60 minutes, until no more spontaneous Sensor movement and rotation are observed. Then IOP will be measured on the contra lateral eye using Goldmann tonometer and the subjects will be asked to drink 1 liter of water within 5 minutes. After the water drinking, IOP will be measured on the contra lateral eye 10 minutes after the beginning of the test then every 5 minutes until returned to normal. The IOP will be measured again every 20 minutes until 2 hours after the water drinking.

Interventions

DEVICESENSIMED Triggerfish®

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteer without previous ocular medical history * 18 years or more at inclusion * Maximal weight: 100kg * BMI lower or equal to 30 kg/m2 * Subjects having provided informed consent

Exclusion criteria

* Silicone allergy * Cardiovascular disease * Diabetes * Narrow or closed iridocorneal angle

Design outcomes

Primary

Measure	Time frame
SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT	30-45 min after WDT

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026